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Pregabalin Pfizer 20 February 2014 EMA/174304/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pregabalin Pfizer International non-proprietary name: Pregabalin Procedure No. EMEA/H/C/003880/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E (...) ) to the European Medicines Agency (EMA) for Pregabalin Pfizer, through the centralised procedure. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 24 October 2013. The applicant applied for the following indications: • Neuropathic pain Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults. • Epilepsy Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation
Pregabalin USE OF PREGABALIN IN PREGNANCY 0344 892 0909 USE OF PREGABALIN IN PREGNANCY (Date of issue: June 2016 , Version: 3.1 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Pregabalin is an anticonvulsant used as adjunctive therapy in adults (...) with partial seizures, with or without secondary generalisation, and in the treatment of neuropathic pain and generalised anxiety disorder. There is limited information on the use of pregabalin in pregnancy, with less than 200 exposures in the published literature. Fetal toxicity has been reported in animal studies. A prospective cohort study found a significant increased risk of major malformation in comparison with unexposed controls, however these findings are limited by the small number of exposed
Pregabalin in Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy: A Randomized Withdrawal Trial This study used a randomized withdrawal design to evaluate the efficacy of pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy inadequately treated by other therapies.A total of 665 patients received pregabalin in a 6-week single-blind phase. Two hundred ninety-four patients who achieved a ≥ 30% pain response were randomized (...) to receive pregabalin or placebo in a double-blind phase for a further 13 weeks. The primary endpoint was the change in mean pain score from single-blind baseline to double-blind endpoint for pregabalin versus placebo (last observation carried forward [LOCF]). Secondary endpoints included a baseline observation carried forward (BOCF) analysis of mean pain score; time to loss of pain response; and other assessments of pain, sleep, function, and quality of life (QOL).Pregabalin numerically improved all
Combination of Pregabalin and Dexamethasone for Postoperative Pain and Functional Outcome in Patients Undergoing Lumbar Spinal Surgery: A Randomized Placebo-controlled Trial In this randomized-controlled study, we investigated the effects of combined administration of pregabalin and dexamethasone on postoperative pain and analgesic requirements, and functional outcome in patients who underwent lumbar spinal surgery.One hundred eight patients were randomized to group C (placebo+placebo), group P (...) (pregabalin + placebo), or group PD (pregabalin+dexamethasone). According to their allocated group, patients received placebo or pregabalin 150 mg every 12 hours starting 1 hour before anesthetic induction for a total of 8 doses. Dexamethasone 16 mg or normal saline was injected before the induction of anesthesia. The pain intensity, analgesic requirements, and side effects were assessed in the postoperative period: postanesthesia care unit, 12, 24, 48, and 72 hours. Pain intensity and daily activity
A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain A cost-utility study of the use of pregabalin in treatment-refractory neuropathic pain Gordon J, Lister S, Prettyjohns M, McEwan P, Tetlow A, Gabriel Z Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods (...) , the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to assess the cost-effectiveness of pregabalin for patients with refractory neuropathic pain. The authors concluded that it was a cost-effective alternative to usual care. On the whole, the methods were well reported and the authors' conclusions seem valid for pregabalin in addition to usual care, rather than as an alternative. Type of economic
Abuse and misuse potential of pregabalin: a review of the clinical evidence Abuse and misuse potential of pregabalin: a review of the clinical evidence Abuse and misuse potential of pregabalin: a review of the clinical evidence CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Abuse and misuse potential of pregabalin: a review (...) of the clinical evidence. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2012 Authors' conclusions There is a limited volume of evidence regarding the abuse and misuse potential of pregabalin. Existing evidence is generally of low quality and suggests that certain populations with a history of substance abuse may be at increased risk to abuse pregabalin. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Analgesics; Anticonvulsants; Drug and Narcotic Controls
The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective The cost-effectiveness of pregabalin in the treatment of fibromyalgia: US perspective Lloyd A, Boomershine CS, Choy EH, Chandran A, Zlateva G Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results (...) and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The study examined the cost-effectiveness of pregabalin for treatment of severe fibromyalgia compared with placebo, duloxetine, milnacipran, gabapentin, tramadol and amitriptyline. The authors concluded that pregabalin was more beneficial and less expensive than the other available treatments for severe fibromyalgia, except when compared to amitriptyline. The study used valid
Pregabalin for chronic prostatitis. Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a condition that is detrimental to the quality of life of men. Evidence suggests that it may have a neuropathic origin and therefore medications such as pregabalin might have a role in the controlling of symptoms.The primary objective was to compare pregabalin to other modalities of pain relief to alleviate men's symptoms of CP/CPPS.The secondary objective was to assess the safety and effectiveness (...) of pregabalin to improve various individual symptoms consistent with CP/CPPS.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2012), EMBASE (1980 to May 2012), CINAHL, clinicaltrials.gov, Google Scholar, and reference lists of articles and abstracts from conference proceedings, without language restriction for pregabalin treatment of Class III prostatitis and CP/CPPS.Randomized controlled trials (RCTs) comparing pregabalin to placebo or other types of analgesics
Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients.We performed a randomized, double-blind, placebo-controlled, 2-period crossover PSG study. Patients ages ≥18 years with fibromyalgia satisfied subjective and objective sleep (...) disturbance criteria prior to randomization. Eligible patients were randomized (1:1) to pregabalin (300-450 mg/day) or placebo for crossover period 1, and vice versa for period 2. Each crossover period comprised a dose-adjustment and dose-maintenance phase, with a 2-week taper/washout between periods. In-laboratory PSGs were recorded during 2 consecutive nights at screening and at the end of each crossover period. The primary end point was the difference in sleep maintenance defined by PSG-recorded wake
Abuse and Misuse Potential of Pregabalin: A Review of the Clinical Evidence Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses (...) : This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. TITLE: Abuse and Misuse Potential of Pregabalin: A Review of the Clinical Evidence DATE: 24 April 2012 CONTEXT AND POLICY ISSUES Pregabalin (Lyrica) is an anticonvulsant approved in Canada and the United States (US) since 2005 to treat neuropathic pain
Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? BestBets: Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? Can pregabalin effectively diminish acute herpetic pain and reduce the incidence of post-herpetic neuralgia in patients who present with acute herpes zoster? Report (...) By: Eliane Raymond-Dufresne - PGY-3, Emergency Medicine Search checked by Katharine Wylie - Senior Informatacist Institution: Laval University, Québec, Canada Date Submitted: 23rd November 2011 Date Completed: 13th February 2012 Last Modified: 20th February 2012 Status: Green (complete) Three Part Question In [patients with new onset of herpes zoster infection], can [pregabalin] be used to [decrease the incidence of post-herpetic neuralgia and to decrease the intensity of acute herpetic pain]? Clinical
The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Pregabalin reduces pain in patients with chronic pancreatitis in a randomized, controlled trial Pain is a disabling symptom for patients with chronic pancreatitis (CP) and difficult to treat. Evidence from basic science and human studies indicates that pain processing by the central nervous system is abnormal and resembles that observed in patients with neuropathic pain disorders. We investigated whether agents used to treat patients with neuropathic pain are effective in CP.We conducted (...) a randomized, double-blind, placebo-controlled trial to evaluate the effects of the gabapentoid pregabalin as an adjuvant analgesic. We measured pain relief, health status, quality of life, and tolerability in 64 patients with pain from CP; they were randomly assigned to groups given increasing doses of pregabalin or placebo (control) for 3 consecutive weeks. The primary end point was pain relief, based on a visual analogue scale documented by a pain diary. Secondary end points included Patients' Global
Safety and efficacy of pregabalin in patients with central post-stroke pain. Pregabalin has demonstrated efficacy in several forms of neuropathic pain, but its long-term efficacy in central post-stroke pain (CPSP) is unproven. We evaluated the efficacy and safety of pregabalin versus placebo in patients with CPSP. A 13-week, randomized, double-blind, multicenter, placebo-controlled, parallel group study of 150 to 600 mg/day pregabalin was conducted in patients aged ≥18 years with CPSP (...) . The primary efficacy endpoint was the mean pain score on the Daily Pain Rating Scale over the last 7 days on study drug up to week 12 or early termination visit. Secondary endpoints included other pain parameters and patient-reported sleep and health-related quality-of-life measures. A total of 219 patients were treated (pregabalin n=110; placebo n=109). A mean pain score at baseline of 6.5 in the pregabalin group and 6.3 in the placebo group reduced at endpoint to 4.9 in the pregabalin group and 5.0
Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial To date, published neuropathic pain randomized controlled trials of pregabalin have involved primarily diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). This multicenter trial evaluated pregabalin in a broader range of neuropathic pain etiologies.In this enriched enrollment randomized withdrawal trial, 256 patients received single blind, flexible (...) dose pregabalin for 4 weeks; stable concomitant analgesics were allowed. One hundred sixty-five (65%) had a ≥30% pain improvement and 157 were randomized and treated, double blind, to either continue pregabalin (n=80) or to receive placebo (n=77) for 5 weeks.Of the single blind responders randomized, 81% on placebo and 86% on pregabalin completed the double-blind phase. At the double-blind endpoint, mean (SD) pain scores were 2.9 (1.9) in the pregabalin group and 3.5 (1.7) in the placebo group (P
Effective Dose of Peri-operative Oral Pregabalin as an Adjunct to Multimodal Analgesic Regimen in Lumbar Spinal Fusion Surgery A prospective, randomized, controlled, and double-blind trial.To evaluate the effects of 2 different doses of perioperative pregabalin administration, twice on the day of surgery, on acute postoperative pain after spinal surgery.Besides its well-established role on neuropathic pain, pregabalin seems to be a promising adjunct to multimodal analgesic regimen following (...) surgery. No comprehensive data exist regarding the optimal dosage of pregabalin on reducing postoperative pain and opioid consumption in spinal surgery.Patients were randomly assigned to 1 of 3 groups. The placebo group (n = 28) received placebo capsules 1 hour before the anesthetic induction and 12 hours after surgery. The pregabalin groups received pregabalin 75 mg (P75 group, n = 28) or 150 mg (P150 group, n = 28), respectively at the same points. Assessed variables were total amount
A meta-analysis of the efficacy of pregabalin in the treatment of generalized anxiety disorder A meta-analysis of the efficacy of pregabalin in the treatment of generalized anxiety disorder A meta-analysis of the efficacy of pregabalin in the treatment of generalized anxiety disorder Boschen MJ CRD summary The review concluded that pregabalin was an effective treatment for generalised anxiety disorder compared to placebo. Given limitations in the review process as well as uncertain quality (...) of the included trials the authors conclusion may not be reliable. Authors' objectives To determine the efficacy of pregabalin for treatment of generalised anxiety disorder. Searching PubMed was searched up to December 2010 for relevant published peer-reviewed trials. Search terms were reported. References lists were searched. Study selection Randomised controlled trials (RCTs) that compared pregabalin with placebo for treatment of primary generalised anxiety disorder were eligible for inclusion in the review
The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy We evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy. This randomized, controlled, withdrawal trial included five phases: screening (4-18 days); run-in (4-10 days) to screen out placebo responders; single-blind (28 days) to identify pregabalin responders; double-blind to randomize responders to pregabalin or placebo (35 days (...) ); and final study medication taper (7 days). The primary endpoint was time to loss of response (LOR) during the double-blind phase (1-point increase in pain, discontinuation, or rescue-medication use). In the single-blind phase, 58% of patients had 30% pain reduction. In the double-blind phase, pregabalin (n=110) and placebo (n=107) groups did not differ significantly in time to LOR. Adverse events caused the discontinuation of 9.9% and 5.6% of pregabalin-treated and placebo-treated patients, respectively
Pregabalin for the treatment of men with chronic prostatitis/chronic pelvic pain syndrome: a randomized controlled trial Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS (...) symptoms. In 2006-2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed.Of 218 men assigned
A randomized, controlled trial of oxycodone versus placebo in patients with postherpetic neuralgia and painful diabetic neuropathy treated with pregabalin The aim of this randomized double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy, safety, and tolerability of pregabalin in combination with oxycodone or placebo, in patients with either postherpetic neuralgia (PHN) or painful diabetic neuropathy (PDN). After a 7-day washout period, 62 patients were randomized (...) to receive either oxycodone mixture 10 mg/day or placebo mixture for 1 week. Patients were then started on open-label pregabalin (75, 150, 300 and 600 mg/day) according to a forced titration dosing regimen, while continuing the same dosage of oxycodone or placebo for 4 weeks. The primary efficacy measure was a decrease in the pain-intensity score of at least 2cm and a pain score <4cm measured using a 10-cm visual analogue scale (VAS) following pregabalin dosage escalation and treatment for 4 weeks